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COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches
Session Chair(s)
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs
Novo Nordisk, Denmark
This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.
Learning Objective : Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.
Speaker(s)
DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Stine Hasling Mogensen, MPharm
Danish Medicines Agency, Denmark
Senior Scientific Advisor
Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Anton Pottegaard, DrSc, PhD, MPharm
University of Southern Denmark, Denmark
Head of Research at the Hospital Pharmacy; Professor
Off-Label Use Monitoring Through Danish Registries
Mona Vestergaard Laursen, MPharm
Danish Medicines Agency, Denmark
Senior Advisor, Data Analytics Centre
FDA Real-World Evidence Activities Related to Covid19
Mitra Rocca, MSc
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
Richard Forshee, PhD
FDA, United States
Deputy Director, OBPV CBER
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